Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers (PCS IV)

• ClinicalTrials.gov Identifier: NCT00223171
• Recruitment Status: Unknown
• First Posted: September 22, 2005
• Last Update Posted: May 26, 2022
• Sponsor: Université de Sherbrooke
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Abdenour Nabid, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: May 26, 2022
• Study Start Date: October 2000
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 18, 2013)

• Specific survival [ Time Frame: 10 years ]
• Overall survival [ Time Frame: 10 years ]
• Treatment morbidity induced versus quality of life based on duration of hormonal therapy [ Time Frame: 10 years ]

Original Primary Outcome Measures (submitted: September 13, 2005)

• Specific survival
• Overall survival
• Treatment morbidity induced versus quality of life based on duration of hormonal therapy

Current Secondary Outcome Measures (submitted: July 18, 2013)

• Disease-free survival [ Time Frame: 10 years ]
• Site of tumour relapse [ Time Frame: 10 years ]
• Interval until first biochemical failure [ Time Frame: 10 years ]
• Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour) [ Time Frame: 10 years ]

Original Secondary Outcome Measures (submitted: September 13, 2005)

• Disease-free survival
• Site of tumour relapse
• Interval until first biochemical failure
• Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers
• Official Title: Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers
• Brief Summary: The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

Drug: Androgen blockade + radiation therapy

Androgen blockade + radiation therapy

Study Arms

• Active Comparator: Arm 1 : 36 months AB + RT
  Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)
  Intervention: Drug: Androgen blockade + radiation therapy
• Experimental: Arm 2 : 18 months AB + RT
  Androgen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)
  Intervention: Drug: Androgen blockade + radiation therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: May 20, 2022): 630
• Original Enrollment (submitted: September 13, 2005): 600
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• To have at least one of the following three risk factors:

  • Tumour classified T3 or T4
  • Gleason score 8-10
  • Prostate-specific antigen (PSA) level > 20
• Performance status score of 0-1.
• Patients must sign a consent form before the start of the study.
• No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [CAT] scan, magnetic resonance imaging [MRI], lymphography) or surgical staging or negative pelvic node dissection.
• No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization.
• Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
• Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
• The patient must be available for treatments and follow-up visits.
• Treatments must start in the three weeks following randomization.

Exclusion Criteria:

• Severe medical or psychiatric problems that could compromise study compliance.
• Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00223171
• Other Study ID Numbers: DC-990-0056,1; DC-990-0056
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abdenour Nabid, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Original Responsible Party: Not Provided
• Current Study Sponsor: Université de Sherbrooke
• Original Study Sponsor: Same as current
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: Abdenour Nabid, MD; Centre de Recherche Clinique Étienne LeBel/CHUS Fleurimont

• PRS Account: Université de Sherbrooke
• Verification Date: May 2022